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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026375
Receipt No. R000030310
Scientific Title Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Date of disclosure of the study information 2017/03/02
Last modified on 2021/06/28

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Basic information
Public title Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Acronym Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.
Scientific Title Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Scientific Title:Acronym Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.
Region
Japan

Condition
Condition Non-Small-Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Basic objectives2 Others
Basic objectives -Others Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.
Key secondary outcomes Relationship between variation of bacterial flora and therapeutic effect, AEs or PD-L1 expression.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non-small cell lung cancer
2)Pretreated NSCLC, without immune chekpoint inhibitor
3)ECOG PS : 0-2
4)When taking lactobacillus preparation (including marketing medicines), it can be canceled from one week before registration to the end of observation period.
5)At least one measurable lesion by RECIST
6)Life expectancy more than 12 weeks.
7)Written informed consent.
8)Patients who have had the following administration periods from the previous treatment
A.chemotherapy:Not specified
B.radiation
chest: >4weeks
Other than chest: >2 weeks
C.surgery
major: >4weeks
minor: >2weeks
Key exclusion criteria 1)With active or history of Interstitial pneumonia.
2)Interstitial change or pulmonary fibrosis detectable on X ray
3)Autoimmune disease.
4)Patients receiving corticosteroids (up to 10 mg/day in terms of prednisolone is acceptable) or immunosuppressants within 2 weeks before registration.
5)Patients receiving antibiotics within 5 weeks before registration
6)Patients who are pregnant or nursing
7)With active or history of inflammatory bowel disease.
8)Evaluated to be ineligible by a physician for other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name TAKASHI
Middle name
Last name YOKOI
Organization Hyogo College of Medicine
Division name Department of Thoracic Oncology
Zip code 663-8501
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6596
Email ta-yokoi@hyo-med.ac.jp

Public contact
Name of contact person
1st name RYO
Middle name
Last name ITOTANI
Organization Kitano Hospital
Division name Respiratory medicine
Zip code 530-8480
Address 2-4-20, Ogimachi, Kita-ku, Osaka-city
TEL 06-6312-1221
Homepage URL
Email itotani@kitano-hp.or.jp

Sponsor
Institute Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Review Board of Hyogo College of Medicine
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel 0798-45-6111
Email rinri@hyo-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫医科大学病院、関西医科大学附属病院、北野病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 02 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000030310
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000030310
Number of participants that the trial has enrolled 32
Results ・Primary
1. Relationship between DCR and gut microbiota. : No significant difference was observed in all bacterial species.
2. Relationship between ORR and gut microbiota.:
Clostridium subcluster XIVa showed a significant correlation (HR:1.146, 95% C.I.:1.025-1.282, p=0.0165). But no significant difference was found in other species.
・Secondary
Relationship between ORR and changes in gut microbiota.: No significant difference was observed in all bacterial species.
Results date posted
2021 Year 06 Month 28 Day
Results Delayed
Delay expected
Results Delay Reason Result analysis and treatise writing are delayed.
Date of the first journal publication of results
Baseline Characteristics Patient characteristics of 27 patients whose consent was obtained and whose stool samples could be collected and analyzed.

Median age: 70 years (46-88)
Gender: 25 males, 2 females
Stage: III 8 cases, IV 13 cases, postoperative recurrence 6 cases
Smoking history: 25 smoker, 2 non-smoker
Gene mutation: Yes 3 cases, No 20 cases, Unknown 4 cases
Participant flow This study is multicenter observational study to evaluate the relationship between gut bacterial flora and therapeutic effects and/or adverse events in advanced non-small cell lung cancer patients treated with nivolumab.
Adverse events Fatigue; Grede1: 5 cases (15.6%)
ILD; Grade 1: 3 cases (8.6%), Grade 3: 1 case (2.9%)
Hypothyroidism; Grade 1: 5 cases (15.6%), Grade 2: 1 case (2.9%)
Rash; Grade 1: 4 cases (11.4%)
Stomatitis; Grade1: 1 case (2.9%)
Diarrhea; Grade 1: 1 case (2.9%)
Liver damage; Grade 3: 1 case (2.9%)
Constipation; Grade 1: 1 case (2.9%), Grade 2: 1 case (2.9%)
Acute exacerbation of COPD; Grade 3: 1 case (2.9%)
Outcome measures Primary objectives;
To evaluate the relationship between intestinal gut bacterial flora and therapeutic effect and/or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Secondary objectives;
To evaluate the relationship between the alteration of gut bacterial flora and therapeutic effects and/or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 21 Day
Date of IRB
2017 Year 09 Month 08 Day
Anticipated trial start date
2017 Year 03 Month 02 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.

Management information
Registered date
2017 Year 03 Month 02 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030310

Research Plan
Registered date File name
2021/06/16 KCOG1615研究計画書v3.1.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/04/22 20190422.xlsx


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